For doctors

Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Teva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Teva is used

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Irbesartan Teva a. If you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of this medicine. b. If you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).

Irbesartan Teva should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan Teva Tell your doctor if any of the following apply to you:

If you are going to have an operation (surgery) or be given anaesthetics.

You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Teva is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan Teva does not usually interact with other medicines.

You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium-sparing medicines (such as certain diuretics)

medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan Teva with food and drinkIrbesartan Teva can be taken with or without food.

Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva. Irbesartan Teva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machinesNo studies on the effects on the ability to drive and use machines have been performed. Irbesartan Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Always take Irbesartan Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration Irbesartan Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Teva until your doctor tells you otherwise.

Patients with high blood pressure The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

Like all medicines, Irbesartan Teva can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported in clinical studies for patients treated with irbesartan were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Some undesirable effects have been reported since marketing of irbesartan but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

For doctors

Irbesartan Teva is a medicine that contains the active substance irbesartan. It is available as white tablets (75, 150 and 300 mg). Irbesartan Teva is a ‘generic medicine’. This means that Irbesartan Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aprovel. For more information on generic medicines, see the question-and-answer document here.

Irbesartan Teva is used in patients who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). Irbesartan Teva is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group. The medicine can only be obtained with a prescription.

Irbesartan Teva is taken by mouth, with or without food. The usual recommended dose is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age. In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

The active substance in Irbesartan Teva, irbesartan, is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Teva has been shown to have comparable quality and to be bioequivalent to Aprovel. Therefore, the CHMP’s view was that, as for Aprovel, the benefit outweighs the identified risk. The Committee recommended that Irbesartan Teva be given marketing authorisation.